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A randomised controlled trial of triclosan coated sutures in primary total hip and total knee arthroplasty

Condition category

Surgery

Date applied

25/07/2013

Date assigned

20/08/2013

Last edited

20/08/2013

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsAlthough safer than ever, infections after hip and knee replacements remain a challenging problem. Managing such infections often requires a long course of treatment and can lead to unhappy patients with poor function of the joint. We are always looking for ways to prevent infection, as it has been proven that prevention, rather than treatment, provides the best outcome for our patients.The purpose of this study is to find out whether sutures (stitches) coated with an antiseptic agent called triclosan are able to reduce infections within a surgical wound, in people having total hip and total knee replacements. Triclosan is not a new drug and has been used for more than 30 years in toothpaste, cosmetics and antiseptic soaps. Triclosan-coated sutures have been successfully used to reduce infections after heart surgery, abdominal surgery and neurosurgery. We hope that the use of triclosan-coated sutures will work in a similar way when used in total hip and total knee replacements.

Who can participate? Patients aged 18 or over undergoing primary hip or knee replacements in the Department of Trauma and Orthopaedics at University College London Hospital can participate in the study.

What does the study involve? The patients are randomly allocated to one of two groups. One group of participants will receive triclosan-coated sutures during surgery and a second group will receive an ordinary suture without triclosan. Neither the patient nor the investigator will know which group the patient will be in. At the end of the operation the deep layers of the wound will be stitched using either the triclosan-coated suture or the ordinary suture. The outside skin will be closed as normal, using clips for both groups. This is the only difference between the two groups. The patient will then receive our standard postoperative treatment for people undergoing total hip or total knee replacements. There will be an extra clinic for the patient to attend at the hospital 2 weeks after the operation for inspection of the wound and removal of the skin clips rather than having that done at the GP surgery. Additionally, at the time of discharge the patient will be given a simple yes/no questionnaire regarding their wound, which they will be asked to complete and return in a pre-paid envelope two months after the operation.

What are the possible benefits and risks of participating?We do not know for certain if triclosan-coated sutures will improve the wound healing or reduce infection rates in total hip and total knee replacements. However, there is a chance that these sutures will improve recovery time and joint function for hip and knee replacements. There may not be any benefit to you directly if you are placed in the group which will receive an ordinary suture without triclosan.Minimal inflammation of the surrounding tissues, localised irritation when skin sutures are left in place for greater than 7 days (sutures used in this study will only be used to close the deep layers of the wound), and slower absorption (>70 days) in tissues with poor blood supply as well as allergic reactions in the form of a rash or contact dermatitis have been reported with the use of triclosan. One study showed that triclosan-coated sutures increased the risk of wound separation in breast surgery. However, this was not supported by findings from other studies. Whilst rarely serious, the occurrence of any side effects will be sought while the patient is in hospital and at each subsequent hospital visit. The patient will be asked about hospitalisations, consultations with other medical practitioners and appropriate treatment will be provided according to the underlying problem.

Where is the study run from? University College London Hospital (UK).

When is the study starting and how long is it expected to run for? The study is planned to start in August 2013 and recruitment is estimated to be completed over 2 years.

Who is funding the study? University College London is funding the study.

Who is the main contact?Professor Fares Haddad, principal and chief investigator

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fares Haddad

ORCID ID

Contact details

University College London Hospital 235 Euston Road London NW1 2BU United Kingdom

Study information

Scientific title

Acronym

Study hypothesis

The hypothesis is that triclosan coated sutures may be associated with better wound healing characteristics and fewer infections than standard sutures, and as a result may potentially be more appropriate for total hip and total knee arthroplasty wound closures.

Ethics approval

National Research Ethics Service (NRES) Committee London - Harrow approved the study on 03 June 2013

Study design

Single-centred double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Intervention

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Primary objective is to compare the healing characteristics for wounds closed using coated vicryl (polyglactin 910) plus triclosan, (Ethicon, Inc.) and coated vicryl (polyglactin 910) sutures in patients undergoing primary total hip or knee arthroplasties. The primary outcome will be the comparison of the healing characteristics of the study groups, using the ASEPSIS wound scoring method devised in 1986 by Wilson et al at University College London Hospitals.

Secondary outcome measures

Secondary objectives include recording data pertaining to demographics, procedure type, length of operating time, plus patient factors believed to influence wound healing and infection risk. Complications associated with using both sutures and their influence on early discharge will also be noted, as this may result in improved patient outcomes, cost effectiveness and long term prosthesis survival.